HHS Preparing to Open FDA Offices Overseas

To better safeguard the supply of food and medicines imported into the United States, the U.S. Department of Health and Human Services (HHS) will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced in an Oct. 16 news release.

“In the past year, we’ve upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners, including China,” Secretary Leavitt said.

HHS says department officials are also working to conclude Memoranda of Understanding with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama to work together on product safety. Their collaborations could include sharing respective regulatory systems information and joint workshops and training on the safety of food and medical products. The parties will also find opportunities for joint training for food-borne illnesses and the oversight of food traded internationally.

Some proposals in the action plan require new authorities to be granted by Congress, but to date no legislation has passed, HHS said. Examples include the following:

  • Authorizing the department to accredit highly qualified third parties to evaluate compliance with HHS/FDA requirements.
  • Authorizing HHS/FDA to require certification of designated high-risk products as an additional condition of importation.
  • Authority to refuse admission of imports from a firm that delays, limits, or denies HHS/FDA access to its facilities.
  • Empowering HHS/FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through over 300 ports–of-entry, HHS said.

dec-clearance-sale

Latest posts by admin aapc (see all)

One Response to “HHS Preparing to Open FDA Offices Overseas”

  1. Stephanie Kimbrel says:

    The countries who have been importing their goods into this country should be under the same standards of quality that companies in this country are having to be under. In my profession, (I am a certified coder and auditor) we have to make sure that we comply with definate standards of ethics, compliance and HIPAA requirements, but do my constituants in other countries have to comply as well? It doesn’t appear they do, as they can escape the laws here just by being in a different country. I believe that all this $2 trillion worth of products have been totally sub-standard because no one is forcing the same rules that we have to go by in this country. Perhaps if the rules were the same, would the outsourcing of our products come back here, where it belongs? We have to make everyone accountable, and have them play by the same rules as the US citizens have had to go by for years, including abolishing the “slave labor” issues that China and other countries appear to have. This country outlawed that as well as many child labor issues many years ago. Other countries should also have to obide by the same kind of payroll laws we have here as well.

    Thank you

    Stephanie Kimbrel, CPC, CPC-H
    Longmont, CO

Leave a Reply

Your email address will not be published. Required fields are marked *